AccessGUDID - DEVICE: HuBDIC Leg Massager (06975977230023)

GUDID

Device Identifier (DI) Information

Brand Name: HuBDIC Leg Massager
Version or Model: MD-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dongguan City Umed Technology Co., Ltd

Primary DI Number: 06975977230023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 602090959 *Terms of Use

Device Description: The product is composed of built-in rechargeable lithium battery, air pump, control valve, massage air bag and hot compress. It is used to massage the human calf, which can relieve leg fatigue, improve leg blood circulation and prevent varicose veins.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34489	Pneumatic massager	An pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e0ce35b-fe38-4d31-85bd-67ea0771a233
Public Version Date: August 18, 2023
Public Version Number: 1
DI Record Publish Date: August 10, 2023